Glecaprevir/Pibrentasvir (Mavyret) coverage
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Defines medical necessity, approval criteria, dosing limits, contraindications, and treatment interruption guidance for Mavyret for Medicaid members. Affects prescribers and pharmacy/medical authorization staff processing prior authorization requests.
Added Appendix F for guidance on incomplete adherence and AASLD‑IDSA recommended management of treatment interruptions.
Removed qualifier of 'chronic' from HCV criteria to align with AASLD‑IDSA recommendation to treat both acute and chronic HCV.
Updated pediatric dosing and added oral pellet formulation for pediatric patients (age expansion to 3 years and older).
Coverage Criteria
Initial Therapy — Hepatitis C Infection
Covered when ALL of the following are met:
Exact genotype and prior‑treatment branching preserved from policy.
Dosing and coverage by genotype / treatment experience
Coverage and dosing follow genotype, prior treatment experience, cirrhosis status, and transplantation status per FDA labeling and AASLD‑IDSA recommendations.
Per Dosage and Administration (Appendix F/Table).
See treatment‑experienced dosing rows in Dosage and Administration.
Appendix F / Dosage and Administration references post‑transplant guidance.
Refer to Dosage and Administration and AASLD‑IDSA (October 2022) cited in policy.
Requests for uses that are non‑FDA approved and are not specifically addressed in this policy will not be authorized unless the request is supported by sufficient documentation of efficacy and safety in accordance with the payer's off‑label use policy (CP.PMN.53 for Medicaid) or applicable evidence of coverage documents. Providers requesting coverage for off‑label indications should include supporting clinical evidence and reference the off‑label policy when submitting prior authorization.
The following diagnoses and indications are explicitly not authorized under this policy: non‑FDA approved indications not addressed in this policy (unless supported per the off‑label use policy) and hepatitis C virus (HCV) in members who are treatment‑experienced with both an NS3/4A protease inhibitor and an NS5A inhibitor (examples include combination regimens such as Technivie, Viekira, and Zepatier). These exclusions were added to the policy during prior updates to reflect available treatment evidence and formulary considerations.
This clinical policy is intended as a guide to determining medical necessity for Mavyret and related regimens. Actual coverage of services is subject to the terms, exclusions, and limitations of the member's benefit plan and any applicable state or federal coverage requirements. Providers and authorization staff must confirm member eligibility and benefit design; where conflicts exist, Medicaid provisions govern.
Initial Therapy — Drug-specific Criteria
Initial Therapy — Drug-specific — Initial therapy coverage requires meeting all Approval Criteria A
Initial therapy coverage requires meeting ALL of the Approval Criteria (A. Hepatitis C Infection) and adherence to dosing limits.
This node duplicates the policy’s A. Hepatitis C Infection requirement in the drug‑specific section.
Maximum dose limits as specified in Approval Criteria A.11.
Initial therapy dosing for treatment‑naive patients
Treatment‑naïve dosing for eligible patients:
Per Dosage and Administration (Appendix F Table).
Continuation and Interrupted Therapy
Continuation/Total course — Approval duration and dosing guidance for continuation/total course
Approval duration and dosing guidance for continuation and total course:
Approved duration should be consistent with a regimen in Section IV Dosage and Administration.
Interrupted therapy management — Management of interrupted therapy per AASLD‑IDSA (Appendix F)
Management of interrupted therapy follows AASLD‑IDSA Appendix F recommendations:
Appendix F guidance.
Appendix F guidance.
Provider Actions / Prior Authorization Requirements
Prior authorization required — submit documentation that all Approval Criteria (A.1–A.11) are met
Prior authorization is required and the provider must submit documentation showing that all Approval Criteria A.1–A.11 are met, including a quantitative serum HCV RNA result within the last 6 months, documented genotype and treatment history, age > 3 years, cirrhosis/Child‑Pugh status, HBV status or treatment, and that the prescribed dose does not exceed the age/weight‑based limits in the policy.
- Approval Criteria A.1–A.11 must be met
- HCV RNA (quantitative) within the last 6 months required
- Dose must be within specified age/weight limits
Prior authorization must reflect genotype, treatment‑experience, cirrhosis, transplant, and pediatric dosing
Prior authorization requests must follow the policy’s clinical criteria for dosing and duration based on genotype, prior treatment experience, cirrhosis/Child‑Pugh status, post‑transplant status, and pediatric age/weight thresholds; document prior treatments and genotype where required.
- Genotype‑ and treatment‑experience–based dosing and durations per Section IV (e.g., 3 tablets PO QD for 8 weeks for many treatment‑naïve adults/adolescents)
- Pediatric dosing by weight categories and age thresholds (including expansion to ≥3 years) must be used
Off‑label use referral — follow off‑label policy CP.PMN.53 when policy does not list the use
If the requested use is not listed in the policy and the recent label change provision in Section I.B.1 does not apply, providers must refer the request to the off‑label use policy CP.PMN.53 for Medicaid.
- Use CP.PMN.53 for off‑label requests when not covered in this policy and no recent label change applies
Retreatment — document prior regimen failure and follow preferred retreatment combinations
When seeking retreatment after prior DAA failure, document the prior regimen and failure; the policy references preferred retreatment combinations (e.g., Mavyret plus sofosbuvir 400 mg and weight‑based RBV for certain compensated cirrhosis cases) per AASLD‑IDSA guidance.
- Document prior regimen failure when requesting retreatment
- Preferred retreatment combinations are specified in Appendix/Section IV per AASLD‑IDSA (e.g., Mavyret + sofosbuvir + weight‑based RBV for certain failures)
Documentation submission required — office chart notes and lab results to support criteria
Provider must submit office chart notes and laboratory results supporting that the member meets the approval criteria, including quantitative serum HCV RNA (detectable) within the last 6 months, genotype, treatment history, cirrhosis status, and prescribed dosing information.
- Office chart notes and lab results must be provided
- Include detectable quantitative HCV RNA within 6 months, genotype, treatment history, cirrhosis/Child‑Pugh status, and dosing
Clinical documentation and guideline alignment — reference AASLD‑IDSA and FDA labeling; use pediatric weight/age dosing
Prescribing must be consistent with FDA labeling and AASLD‑IDSA recommendations; providers should reference AASLD‑IDSA guidance for regimen selection and dosing, and follow the pediatric weight/age dosing tables (including pellet formulation and age expansion to ≥3 years) as provided.
- Reference most recent AASLD‑IDSA guideline for regimen selection
- Follow FDA labeling and the policy’s pediatric weight/age dosing tables
Non‑FDA uses and complex prior‑treatment scenarios — may be denied; follow off‑label policy or denials guidance
Requests for non‑FDA indicated uses that are not addressed in this policy, and complex prior‑treatment scenarios such as members experienced with both an NS3/4A protease inhibitor AND an NS5A inhibitor, are not authorized under this policy unless supported by the off‑label policy or otherwise meet criteria for exception.
- Non‑FDA indications not in the policy require off‑label policy support (CP.PMN.53)
- Members experienced with both NS3/4A PI and NS5A inhibitor are excluded unless an exception path is followed
Coverage administrative conditions — subject to benefit terms, exclusions, and state/federal requirements
Coverage is subject to the member’s benefit terms, exclusions, limitations, and applicable state or federal requirements; Medicaid provisions take precedence when in conflict with other program rules.
- Coverage depends on member benefit documents and may be limited by exclusions
- State and federal requirements apply; Medicaid provisions prevail if conflicts exist
Coding and Dosing Thresholds
Definitions and Scoring
Step Therapy / Retreatment Documentation
| Step | Requirement / Action |
|---|---|
| 1 | Document prior regimen failure when seeking retreatment (e.g., prior sofosbuvir/velpatasvir/voxilaprevir or glecaprevir/pibrentasvir failure). For compensated cirrhosis patients with prior DAA failure, preferred retreatment includes Mavyret (3 tablets PO QD) plus sofosbuvir 400 mg and weight‑based ribavirin per AASLD‑IDSA recommendations (October 2022). |
Quantity Limits
Site of Care
Administration and site of care — oral dosing and outpatient monitoring
Mavyret is administered orally; dosing and monitoring should follow the outpatient prescriber’s plan and AASLD‑IDSA guidance per the policy’s Dosage and Administration and Appendix F recommendations.
- Administer as oral tablets (or oral pellet formulation for pediatric patients where applicable).
- Monitor and manage dosing/duration per outpatient prescriber and AASLD‑IDSA recommendations, including guidance for missed doses in Appendix F.
Background
Mavyret is a fixed‑dose combination of the NS3/4A protease inhibitor glecaprevir and the NS5A inhibitor pibrentasvir indicated for the treatment of hepatitis C virus (HCV) genotypes 1–6 in adults and pediatric patients aged ≥3 years without cirrhosis or with compensated cirrhosis (Child‑Pugh A). The policy aligns dosing and regimen selection with FDA labeling and AASLD‑IDSA guidance, notes available tablet and oral pellet formulations for pediatric use, and incorporates guidance on treatment interruptions and HBV reactivation risk from AASLD‑IDSA resources.
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